FDA Adverse Event
Malfunction
Summary report: N
SCHNEIDER C-THRU FLOPPY CORONARY GUIDEWIRE
MDR report key: 161034
·
Received March 30, 1998
Report
- Report Number
- 8043892-1998-00163
- Event Type
- Malfunction
- Date Received
- March 30, 1998
- Date of Event
- July 1, 1997
- Report Date
- March 27, 1998
- Manufacturer
- SCHNEIDER (EUROPE) AG
- Product Code
- DQX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PER REPORT RECEIVED FROM FOREIGN MFR: THIS GUIDEWIRE BECAME STUCK INSIDE A PTCA BALLOON CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCHNEIDER C-THRU FLOPPY CORONARY GUIDEWIRE | CORONARY GUIDEWIRE | DQX | SCHNEIDER (EUROPE) AG | SCH-30663 | 7D0653 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |